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COPD across America – How is your state is doing?

WASHINGTON, D.C. – November 30, 2018 – The COPD Foundation is pleased to announce the results of a landmark effort that examines the burden of COPD across America. The “COPD in the United States” project looks at COPD at the state level, identifying differences across states, regions and data points, to inform public health and policy decision-making.

COPD affects an estimated 30 million Americans but, up until now, little has been known about how one state compares to another. With the addition in 2011 of a COPD question to the Centers for Disease Control and Prevention’s Behavioral Risk Factor Surveillance System (BRFSS), the nation’s largest public health survey, more actionable information has been collected. State level data also exists to highlight the healthcare services individuals with COPD use, other conditions people with COPD may have and how different groups of people with COPD are affected.

Just collecting data isn’t enough, though, as it often sits in fragmented databases, is not analyzed or available for advocates, public health and policy decision-makers. With this project, the COPD Foundation aims to change that.

YUPELRI (revefenacin) is the first and only once-daily, nebulized bronchodilator approved for the treatment of COPD in the US

DUBLIN, Ireland, HERTFORDSHIRE, England and PITTSBURGH, Nov. 9, 2018 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma") and Mylan N.V. (NASDAQ: MYL) ("Mylan") today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for YUPELRITM (revefenacin) inhalation solution for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). YUPELRI, a long-acting muscarinic antagonist (LAMA), is the first and only once-daily, nebulized bronchodilator approved for the treatment of COPD in the US. The companies expect YUPELRI to be available to COPD patients in the US before the end of the year. COPD is the third leading cause of death and the fourth leading cause of hospital readmissions in the US, affecting approximately 16 million Americans.

A group of patient and physician groups react to the final rule on Durable Medical Equipment (DME) and its application to supplemental oxygen:

While our organizations appreciate that members of Congress and the Centers for Medicare and Medicaid Services (CMS) recognize the numerous problems associated with patient access to oxygen in general and liquid oxygen systems, we believe that CMS’s decision today will not ultimately solve the problems facing patients who require supplemental oxygen. More link to https://www.lung.org/about-us/media/press-releases/patient-and-physician-groups-cms.html.

COPD Pocket Consultant Guide App now available for both iOS and Android

WASHINGTON, D.C. - November 5, 2018 –The COPD Foundation is excited to announce the launch of the COPD Pocket Consultant Guide (PCG) app for healthcare providers. The app, designed to support the treatment and management of COPD, is now available for both iOS and Android. To download the new COPD PCG app, click here.

Key features of the COPD PCG app include an updated therapy chart including the latest medications for COPD, inhaler instruction videos, depression and anxiety screeners, links to COPD Foundation resources and more.

Additional features, such as the Fletcher-Peto Impact of Smoking graph and lung volume reduction options, are included in the app as well as links to PRAXIS (the COPD Foundation’s online hub for healthcare providers), the Journal of the COPD Foundation and the National Heart, Lung and Blood Institute’s COPD National Action Plan.

The COPD Foundation’s theme this year is “Hope and Inspiration,” which highlights the organization’s efforts to connect with COPD patients and remind them that COPD does not define them. It also aims to raise public awareness about the disease and showcase the many tools available to patients on their journey while encouraging them and their loved ones to take control of their COPD by learning more about their disease.

A number of activities have been designed to recognize patients, caregivers, friends, family members and healthcare providers impacted by COPD. These include:

Insmed Announces FDA Approval of ARIKAYCE® (amikacin liposome inhalation suspension), the First and Only Therapy Specifically Indicated for the Treatment of Mycobacterium Avium Complex (MAC) Lung Disease in Adult Patients with Limited or No Alternative Treatment Options

BRIDGEWATER, N.J., Sept. 28, 2018 (GLOBE NEWSWIRE) -- Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company focused on the unmet needs of patients with rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of ARIKAYCE® (amikacin liposome inhalation suspension) for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen for adult patients who have limited or no alternative treatment options. ARIKAYCE is the first and only therapy approved in the U.S. specifically for patients with MAC lung disease, a chronic and debilitating condition that can significantly increase patient morbidity and mortality.

ARIKAYCE is the first product approved via the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD). LPAD, which was enacted as part of the 21st Century Cures Act, serves to advance the development of new antibacterial drugs to treat serious or life-threatening infections in limited populations of patients with unmet needs.

“Today’s approval is a momentous occasion for all of us living with and advocating for people with MAC lung disease,” said Philip Leitman, President of Nontuberculous Mycobacteria Info & Research (NTMir). “ARIKAYCE provides a much-needed treatment for patients with this chronic and life-threatening disease who have not responded to the current standard of care. Many of these patients have been suffering for years and face significant challenges in their day-to-day lives, and we are excited to finally have an approved treatment for them.”

Washington, DC– September 7, 2018 – The COPD Foundation today announced the appointment of Byron M. Thomashow, MD, to the newly created position of chief medical officer. In addition to helping found the COPD Foundation, Dr. Thomashow, served as the chairman of the board since 2004. Michael P. Mayer, who recently served as the chairman of the human resources and finance committees for the COPD Foundation Board, has been appointed the Foundation’s newest chair.

Dr. Thomashow is a Professor of Medicine at the Columbia University Medical Center, an Attending Physician at the New York-Presbyterian Hospital and Medical Director of the Jo-Ann LeBuhn Center for Chest Disease on the Columbia campus. He was a member of the steering committee and the co-primary investigator at the Columbia site for the National Emphysema Treatment Trial and has been and remains actively involved in multiple national clinical research projects.

REDWOOD CITY, Calif. – June 29, 2018 – Pulmonx® Corp. announced today that the U.S. Food and Drug Administration (FDA) has approved the Zephyr® Endobronchial Valve System for treating severe emphysema patients. The Zephyr Valve is the first minimally-invasive device approved in the United States for treating patients with severe emphysema, a progressive and life-threatening form of chronic obstructive pulmonary disease (COPD).

The approval is based on positive clinical data from the pivotal LIBERATE Study and two other multicenter randomized control trials. In the LIBERATE study, patients treated with Zephyr Valves were able to breathe easier, be more active and energetic, be less short of breath, and enjoy a significantly improved quality of life compared to patients who received medical management alone.

As stated in the Summary of Safety and Effectiveness Data, the FDA granted the Zephyr Valve an expedited review because it “represents a breakthrough technology as the device offers bronchoscopic lung volume reduction without surgery and its associated risks. This device offers significant clinically meaningful advantage over the current standard of care and therefore its availability is also in the best interest of patients.” “Zephyr Valves are a major step forward in treating severe emphysema patients who consistently feel short of breath despite all the medications we can offer. I have seen Zephyr Valve-treated patients getting back to a more active life doing the things they enjoy. As a physician, it is very gratifying to have a new treatment that can restore a patient’s confidence and change their life for the long term,” said Gerard Criner, MD, FACP, FACCP, Chair and Professor of Thoracic Medicine and Surgery, Lewis Katz School of Medicine at Temple University, and lead investigator for the LIBERATE Study.

WASHINGTON, D.C. – May 23, 2018 – Families of loved ones with mental illness are about to get more help thanks to Caregiver Action Network (CAN). Today Caregiver Action Network is launching a brand new website, Blueprint for Families of a Loved One with Mental Health Issues, to help families address some of the challenges they face when caring for a mentally ill family member.

“Mental illness affects the whole family,” said John Schall, Chief Executive Officer of CAN. “Family caregivers all face big challenges and mental illness adds an additional layer of complexity. Sometimes the patient may even refuse to have any family help at all, insisting that they can manage their illness on their own.”

Caregiver Action Network (CAN).Blueprint for Families of a Loved One with Mental Health Issues provides information specifically tailored to family caregivers of those affected by mental health issues through four resources:

BILLERICA, MA – May 22, 2018 – ProterixBio, Inc. today announced that results from three clinical studies of subjects with chronic obstructive pulmonary disease (COPD) were presented at the American Thoracic Society International Conference this week.

One presentation, “Prospective Evaluation of Algorithms Based on Blood Biomarkers as Guides for COPD Assessment and Risk Stratification,” highlighted that blood biomarker based algorithms associate with propensity for future exacerbations, indicating that advanced molecular assessments may improve the characterization of a patient’s disease activity in advance of potentially avoidable events.

LONDON, UK – May 22, 2018 – Verona Pharma plc, a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for respiratory diseases, today presented Phase 2a and pharmacokinetic data from two clinical trials evaluating its lead product candidate, RPL554, in chronic obstructive pulmonary disease (COPD) at the American Thoracic Society International Conference (ATS 2018), in San Diego. Results from these trials were previously reported by Verona Pharma on September 7, 2017 and September 27, 2017, respectively.

RPL554 is a first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 designed to have anti-inflammatory as well as bronchodilator properties, and is currently in development for the maintenance treatment of COPD and for the treatment of cystic fibrosis.

The poster, titled, “RPL554, A First-In-Class Dual PDE3/4 Inhibitor, Causes Rapid Additional Bronchodilation When Dosed with Tiotropium in COPD Patients,” provided a review of the positive data from Verona Pharma’s Phase 2a clinical trial, in which RPL554 was dosed in addition to tiotropium (Spiriva®), one of the most commonly used drugs to treat COPD. In summary, the data from this Phase 2a trial demonstrated significantly improved peak lung function when RPL554 was added to tiotropium in patients with moderate-to-severe COPD.

OXFORD, UK – May 22, 2018 – Circassia Pharmaceuticals plc, a specialty pharmaceutical company focused on respiratory disease, today announces the presentation of positive clinical data from the Tudorza® Pressair® phase IV ASCENT study and Duaklir® Pressair® phase III AMPLIFY study at the American Thoracic Society (ATS) 2018 International Conference currently being held in San Diego, CA.

Steve Harris, Circassia’s CEO, said: “With both the ASCENT and AMPLIFY studies meeting their primary endpoints, the positive data presented at the American Thoracic Society conference are highly supportive for Tudorza® and Duaklir®. As a result, we look forward to regulatory filings in the coming weeks seeking US approval for Duaklir® and an extension to Tudorza®’s US prescribing information to include the ASCENT data.”

ASCENT phase IV results1
ASCENT evaluated the long-term effect of the long-acting muscarinic antagonist (LAMA) Tudorza® (aclidinium 400μg twice-daily) on cardiovascular safety and chronic obstructive pulmonary disease (COPD) exacerbations. The study was conducted in approximately 3,600 patients with moderate to very severe COPD and cardiovascular disease and / or risk factors. ASCENT was unique in that 48% of patients enrolled had at least one documented previous cardiovascular event while 96% of patients included had at least two atherothrombotic risk factors. ASCENT met its primary endpoints, demonstrating that Tudorza® is effective at reducing exacerbations with no increase in cardiovascular events in this at-risk population. The ATS conference oral presentation included a number of outcome measures: